New Jersey 732.770.4100

 Advanced Clinical Research Associate Training

A Clinical Research Associate in House is a professional employed by a pharmaceutical, medical device manufacturing, or clinical research organization (CRO) to support progress of clinical trials.
CRA ensures the integrity of the trial scientific data collected and the clinical protocol.
Advanced CRA training is designed for experienced professionals to add new skills set. See program highlights for more information

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Admission Requirements   Recommended: minimum a Bachelor degree in biochemistry, biomedical engineering, biotechnology, chemistry, clinical data management, medicine, pharmaceutical engineering, industrial pharmacy, industrial chemistry, public health, pharmacy, pharmaceutical business, pharmacology, or toxicology.
Curriculum Overview The course is designed for experienced professionals to add new skills set and therefore prior training or relevant experience is required. The ACRA covers 15 advanced topics and 15 advanced exercises and provides exposure to diverse CRA responsibilities, real time documentation + advanced learning supported by practical case scenario tasks and follow up process. Specifically, the topics ACRA training covers includes:
  1. Clinical Trial Budget
  2. Investigator Selection
  3. Pre-Study Visit
  4. Protocol
  5. Informed Consent Preparation
  6. Investigational New Drug (IND)
  7. Application
  8. Institutional Review Board (IRB)
  9. Regulatory Correspondence
  10. Case Report Form (CRF)
  11. Site Monitoring
  12. Co-Monitoring Visits
  13. Study Initiation Visit
  14. Clinical Trial Management Systems
  15. (CTMS) Tracking Recording
  16. Trial Master File
  17. Database Lock
  18. Audit
Teaching Methodology Available as self paced training (PIP, pure internet program)
Course Reading Material (PowerPoint presentations and Exercises)
Career Opportunity Pathways Clinical Research Associate (In-House), Clinical Research Monitor, Trial Documentation Specialist, CRA - Trial master File Maintenance, CRA - Trial Documents Validation and CRF Data
Duration 45 days
Program Brochure 'Click here' to download program brochure
Contact Information NJ Office - (P) 732.770.4100
Fax - 888.532.0210
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